NCT02384317

Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

Detailed description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DRUG	CCX168	CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.

Timeline

• Start date: 2015-03-27
• Primary completion: 2015-09-13
• Completion: 2018-06-01
• First posted: 2015-03-10
• Last updated: 2025-03-13
• Results posted: 2023-08-01

Locations

6 sites across 2 countries: United States, Sweden